PARIS (dpa-AFX) - French drug major Sanofi (SNYNF, SNY) said that positive
results from Part 2 of the investigational amlitelimab Phase 2b study STREAM-AD
showed sustained improvement of signs and symptoms for 28 weeks in adults with
moderate to severe atopic dermatitis who previously responded to amlitelimab and
continued treatment. High responder rates were also observed in participants who
were taken off amlitelimab. The safety profile was consistent with Part 1 of the
study with amlitelimab being well-tolerated and no new safety concerns
identified.

The results support the quarterly (every 12-week) dosing of amlitelimab 250 mg
with 500 mg loading dose (LD) now being investigated in a larger Phase 3
clinical program (OCEANA).

In the second part of the dose-ranging STREAM-AD study, responders to
amlitelimab who achieved a 75% improvement in Eczema Area and Severity Index
(EASI-75) score and/or Investigator Global Assessment (IGA) score of 0 or 1
during the 24-week treatment period (Part 1) were re-randomized to explore the
maintenance of clinical response over an additional 28-week period with
continued amlitelimab treatment or amlitelimab withdrawal.

Across all dose arms, patients who continued amlitelimab treatment maintained
high EASI-75 and/or IGA 0/1, IGA 0/1, and EASI-75 responder rates through 28
weeks. High responder rates were also demonstrated among patients who were taken
off treatment.

In 69.2% of patients with continued treatment with amlitelimab 250 mg Q4W with
500 mg loading dose (LD) vs 58.8% of patients withdrawn from treatment IGA 0/1
and/or EASI-75 response was maintained.

An analysis including pooled dose-arms showed that IGA 0/1 response was
maintained in 71.9% of patients with continued treatment vs 57% of patients
withdrawn from treatment. In this analysis, EASI-75 response was maintained in
69% of patients with continued treatment vs. 61.6% of patients withdrawn from
treatment.

The company noted that sustained biomarker reduction suggested the modulation of
immune response and durable disease control via the blockade of OX40L, a non-T
cell depleting mechanism.

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